510(k) · Cleared
ClearedSynthes (Usa) Flexible Humeral Nail (Flex Nail) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · JDS Nail, Fixation, Bone
Cleared on Sep 4, 1997 as substantially equivalent to K953334 (Synthes (Usa), 1995) after a 59-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 4, 1997
- Review
- 59 days
- Class
- Class II
- Product code
- JDS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953334 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK953334 Synthes FlexnailSynthes (Usa) · 1995
- This deviceK972516 Synthes (Usa) Flexible Humeral Nail (Flex Nail) SystemSynthes (Usa) · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953334 | Synthes Flexnail | Synthes (Usa) | 1995 | — |
| 0 (this device) | K972516 | Synthes (Usa) Flexible Humeral Nail (Flex Nail) System | Synthes (Usa) | 1997 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JDS device
- #1 K230761 TRIGEN META-NAIL Nail Systemscore 12.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K953334 | Synthes FlexnailSummary page 1…?/g 1690 Russell Road Paoli, PA 19301 (610) 647-9700 |15 Contact: Angela Silvestri Intramedullary fixation rod Class I1, 21 CFR 888.3020; 888.3040 Synthes FlexNail (K953334) Synthes FlexNail is a flexible, non-reamed, locking intramedullary fixation device that is capable of sharing normal weight-bea… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All JDS devicesJDS Nail, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDS
146in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDS
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDS
497in 2025
MAUDE reports naming product code JDS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 161 |
| 2008 | 1 | — | 0 | 169 |
| 2009 | 0 | — | 3 | 160 |
| 2010 | 0 | — | 2 | 70 |
| 2011 | 1 | — | 0 | 104 |
| 2012 | 0 | — | 0 | 195 |
| 2013 | 1 | — | 4 | 284 |
| 2014 | 0 | — | 0 | 388 |
| 2015 | 1 | — | 0 | 316 |
| 2016 | 0 | — | 0 | 506 |
| 2017 | 0 | — | 1 | 287 |
| 2018 | 0 | — | 0 | 320 |
| 2019 | 0 | — | 0 | 490 |
| 2020 | 3 | 106 | 1 | 643 |
| 2021 | 0 | — | 0 | 630 |
| 2022 | 0 | — | 0 | 589 |
| 2023 | 1 | — | 0 | 357 |
| 2024 | 3 | 146 | 0 | 466 |
| 2025 | 1 | — | 2 | 497 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Synthes FlexNail is intended for treatment of humeral shaft fractures: specifically, it is for treatment of acute humeral shaft fractures, including certain pre- and post-isthmal fractures (including, but not limited to transverse, short oblique, long oblique, butterfly, and segmental fractures, of all grades of comminution); pathologic or impending pathologic fractures; and non- and malunions of the humeral shaft.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972516: Synthes (Usa) Flexible Humeral Nail (Flex Nail) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972516
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026